NCT01161927

Bioequivalence Study of Nizatidine Capsules 300 mg of Dr.Reddy's Laboratories Limited Under Non- Fasting Conditions

A Two-way Crossover Experimental Evaluation of Relative Bioavailabilities of Two Formulations of Nizatidine 300 mg Capsules in Healthy Human Subjects Under Non-fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Dr. Reddy's Laboratories Limited · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare experimental evaluation of relative bioavailabilities in healthy, human subjects under non-fasting conditions.

Detailed description

Open label, balanced, randomized, two-treatment, two-period, two sequence, single dose, crossover, comparative oral bioavailability study in healthy, adult, male human subjects under non-fasting conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Nizatidine	Nizatidine Capsules 300 mg of Dr.Reddy's Laboratories Limited
DRUG	Axid	Axid 300 mg Capsules of Reliant Pharmaceuticals, US

Timeline

• Start date: 2004-07-01
• Primary completion: 2004-09-01
• Completion: 2004-09-01
• First posted: 2010-07-14
• Last updated: 2010-07-14